Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1241-2018 — AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem imp

U.S. FDA — Device Enforcement · United States · 2018-01-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1241-2018
Date of alert: 2018-01-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Encore Medical, Lp
Product category: device
Product type: Devices

Reported risk: Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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